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1.
J Am Coll Emerg Physicians Open ; 2020 Jul 23.
Article in English | MEDLINE | ID: covidwho-1898685

ABSTRACT

SARS-CoV-2 is a novel strain of coronavirus that was first identified in Wuhan, China; it has since spread rapidly throughout the world. Most of the patients with COVID-19 present with respiratory symptoms, including cough, nasal symptoms, fever, and shortness of breath. However, several groups have reported that SARS-CoV-2 can infect the central nervous system via the olfactory bulb followed by spread throughout the brain and peripheral nervous system. This brief report illustrated a 78-year-old man who presented to the emergency department (ED) on March 22, 2020, with chief complaints of dizziness and unsteadiness while walking. He had no symptoms suggestive of COVID-19 on arrival. SARS-CoV-2 nasopharyngeal swab test performed at that time due to his atypical presentation and lymphocytopenia was positive for virus nucleic acids. The neurological symptoms associated with COVID-19 are frequently non-specific and may emerge several days before the respiratory symptoms; as such, identification of patients presenting with these subtle and seemingly unremarkable COVID-19 symptoms will be quite difficult. Added to this, numerous countries still limit testing for SARS-COV-2 to patients presenting with fever or respiratory symptoms. Frontline physicians should be aware of early, non-specific symptoms associated with SARS-CoV-2 infection.

2.
Lancet Microbe ; 1(7): e300-e307, 2020 11.
Article in English | MEDLINE | ID: covidwho-1795951

ABSTRACT

BACKGROUND: Access to rapid diagnosis is key to the control and management of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Laboratory RT-PCR testing is the current standard of care but usually requires a centralised laboratory and significant infrastructure. We describe our diagnostic accuracy assessment of a novel, rapid point-of-care real time RT-PCR CovidNudge test, which requires no laboratory handling or sample pre-processing. METHODS: Between April and May, 2020, we obtained two nasopharyngeal swab samples from individuals in three hospitals in London and Oxford (UK). Samples were collected from three groups: self-referred health-care workers with suspected COVID-19; patients attending emergency departments with suspected COVID-19; and hospital inpatient admissions with or without suspected COVID-19. For the CovidNudge test, nasopharyngeal swabs were inserted directly into a cartridge which contains all reagents and components required for RT-PCR reactions, including multiple technical replicates of seven SARS-CoV-2 gene targets (rdrp1, rdrp2, e-gene, n-gene, n1, n2 and n3) and human ribonuclease P (RNaseP) as sample adequacy control. Swab samples were tested in parallel using the CovidNudge platform, and with standard laboratory RT-PCR using swabs in viral transport medium for processing in a central laboratory. The primary analysis was to compare the sensitivity and specificity of the point-of-care CovidNudge test with laboratory-based testing. FINDINGS: We obtained 386 paired samples: 280 (73%) from self-referred health-care workers, 15 (4%) from patients in the emergency department, and 91 (23%) hospital inpatient admissions. Of the 386 paired samples, 67 tested positive on the CovidNudge point-of-care platform and 71 with standard laboratory RT-PCR. The overall sensitivity of the point-of-care test compared with laboratory-based testing was 94% (95% CI 86-98) with an overall specificity of 100% (99-100). The sensitivity of the test varied by group (self-referred healthcare workers 94% [95% CI 85-98]; patients in the emergency department 100% [48-100]; and hospital inpatient admissions 100% [29-100]). Specificity was consistent between groups (self-referred health-care workers 100% [95% CI 98-100]; patients in the emergency department 100% [69-100]; and hospital inpatient admissions 100% [96-100]). Point of care testing performance was similar during a period of high background prevalence of laboratory positive tests (25% [95% 20-31] in April, 2020) and low prevalence (3% [95% 1-9] in inpatient screening). Amplification of viral nucleocapsid (n1, n2, and n3) and envelope protein gene (e-gene) were most sensitive for detection of spiked SARS-CoV-2 RNA. INTERPRETATION: The CovidNudge platform was a sensitive, specific, and rapid point of care test for the presence of SARS-CoV-2 without laboratory handling or sample pre-processing. The device, which has been implemented in UK hospitals since May, 2020, could enable rapid decisions for clinical care and testing programmes. FUNDING: National Institute of Health Research (NIHR) Imperial Biomedical Research Centre, NIHR Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at Oxford University in partnership with Public Health England, NIHR Biomedical Research Centre Oxford, and DnaNudge.


Subject(s)
COVID-19 , SARS-CoV-2 , COVID-19/diagnosis , Humans , Point-of-Care Testing , RNA, Viral/genetics , Sensitivity and Specificity
3.
Clin Infect Dis ; 73(11): e4197-e4205, 2021 12 06.
Article in English | MEDLINE | ID: covidwho-1560684

ABSTRACT

BACKGROUND: Patients hospitalized with coronavirus disease 2019 (COVID-19) frequently require mechanical ventilation and have high mortality rates. However, the impact of viral burden on these outcomes is unknown. METHODS: We conducted a retrospective cohort study of patients hospitalized with COVID-19 from 30 March 2020 to 30 April 2020 at 2 hospitals in New York City. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load was assessed using cycle threshold (Ct) values from a reverse transcription-polymerase chain reaction assay applied to nasopharyngeal swab samples. We compared characteristics and outcomes of patients with high, medium, and low admission viral loads and assessed whether viral load was independently associated with intubation and in-hospital mortality. RESULTS: We evaluated 678 patients with COVID-19. Higher viral load was associated with increased age, comorbidities, smoking status, and recent chemotherapy. In-hospital mortality was 35.0% (Ct <25; n = 220), 17.6% (Ct 25-30; n = 216), and 6.2% (Ct >30; n = 242) with high, medium, and low viral loads, respectively (P < .001). The risk of intubation was also higher in patients with a high viral load (29.1%) compared with those with a medium (20.8%) or low viral load (14.9%; P < .001). High viral load was independently associated with mortality (adjusted odds ratio [aOR], 6.05; 95% confidence interval [CI], 2.92-12.52) and intubation (aOR, 2.73; 95% CI, 1.68-4.44). CONCLUSIONS: Admission SARS-CoV-2 viral load among hospitalized patients with COVID-19 independently correlates with the risk of intubation and in-hospital mortality. Providing this information to clinicians could potentially be used to guide patient care.


Subject(s)
COVID-19 , SARS-CoV-2 , Humans , Intubation, Intratracheal , Retrospective Studies , Viral Load
4.
Pan Afr Med J ; 38: 55, 2021.
Article in French | MEDLINE | ID: covidwho-1547713

ABSTRACT

The first outbreak of epidemic respiratory disease due to unknown etiology was reported in the Chinese city of Wuhan December 2019. The World Health Organization (WHO) firstly used the term "new coronavirus 2019" on December 29, 2019. This pandemic, which is currently called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a disease caused by SARS-CoV-2. It was subsequently called coronavirus disease 2019 (COVID-19) by the WHO. The purpose of this study was to determine the prevalence of antibodies against SARS-CoV-2 in all employees of the Nouakchott National Hospital Center (CHN). The study was conducted during the week 20/05/2020 to 27/05/2020. It involved 853 employees of all ranks (doctors, pharmacists, nurses, secretaries, security personnel, administrators...) of whom 504 were male and 331 were female, with a sex ratio of 1,52 with an average age of 39 years, ranging from 20 to 60 years. The screening for IgG and IgM antibodies to SARS-CoV-2 was performed using Biotime (Xiamen Biotime Biotechnology Co., Ltd.) immunochromatographic technique. Out of 835 employees included in our study, 14 were positive (1.67%) of whom 12 had IgM and IgG anti-SARS-CoV-2 antibodies and 2 had isolated IgM. Nasopharyngeal swab polymerase chain reaction (PCR) was performed in these 14 patients and was positive in six. While PCR is the gold standard for the diagnosis of SARS-CoV-2, serological tests for SARS-CoV-2 antibodies, in particular rapid tests (RDTs) are a diagnostic complement to COVID-19. They have the advantage of being easy to realize, of being safe both in the laboratories and outside the laboratories. RDTs enabled us to detect asymptomatic SARS-CoV-2 carriers within CHN employees. This allowed for patients management and isolation to protect patients and their environments.


Subject(s)
COVID-19 Testing , COVID-19/diagnosis , Health Personnel , SARS-CoV-2/isolation & purification , Adult , Antibodies, Viral/blood , COVID-19/epidemiology , Female , Humans , Immunoglobulin G/immunology , Immunoglobulin M/immunology , Male , Mauritania/epidemiology , Middle Aged , Serologic Tests/methods , Young Adult
5.
Lancet Oncol ; 22(6): 765-778, 2021 06.
Article in English | MEDLINE | ID: covidwho-1531901

ABSTRACT

BACKGROUND: The efficacy and safety profiles of vaccines against SARS-CoV-2 in patients with cancer is unknown. We aimed to assess the safety and immunogenicity of the BNT162b2 (Pfizer-BioNTech) vaccine in patients with cancer. METHODS: For this prospective observational study, we recruited patients with cancer and healthy controls (mostly health-care workers) from three London hospitals between Dec 8, 2020, and Feb 18, 2021. Participants who were vaccinated between Dec 8 and Dec 29, 2020, received two 30 µg doses of BNT162b2 administered intramuscularly 21 days apart; patients vaccinated after this date received only one 30 µg dose with a planned follow-up boost at 12 weeks. Blood samples were taken before vaccination and at 3 weeks and 5 weeks after the first vaccination. Where possible, serial nasopharyngeal real-time RT-PCR (rRT-PCR) swab tests were done every 10 days or in cases of symptomatic COVID-19. The coprimary endpoints were seroconversion to SARS-CoV-2 spike (S) protein in patients with cancer following the first vaccination with the BNT162b2 vaccine and the effect of vaccine boosting after 21 days on seroconversion. All participants with available data were included in the safety and immunogenicity analyses. Ongoing follow-up is underway for further blood sampling after the delayed (12-week) vaccine boost. This study is registered with the NHS Health Research Authority and Health and Care Research Wales (REC ID 20/HRA/2031). FINDINGS: 151 patients with cancer (95 patients with solid cancer and 56 patients with haematological cancer) and 54 healthy controls were enrolled. For this interim data analysis of the safety and immunogenicity of vaccinated patients with cancer, samples and data obtained up to March 19, 2021, were analysed. After exclusion of 17 patients who had been exposed to SARS-CoV-2 (detected by either antibody seroconversion or a positive rRT-PCR COVID-19 swab test) from the immunogenicity analysis, the proportion of positive anti-S IgG titres at approximately 21 days following a single vaccine inoculum across the three cohorts were 32 (94%; 95% CI 81-98) of 34 healthy controls; 21 (38%; 26-51) of 56 patients with solid cancer, and eight (18%; 10-32) of 44 patients with haematological cancer. 16 healthy controls, 25 patients with solid cancer, and six patients with haematological cancer received a second dose on day 21. Of the patients with available blood samples 2 weeks following a 21-day vaccine boost, and excluding 17 participants with evidence of previous natural SARS-CoV-2 exposure, 18 (95%; 95% CI 75-99) of 19 patients with solid cancer, 12 (100%; 76-100) of 12 healthy controls, and three (60%; 23-88) of five patients with haematological cancers were seropositive, compared with ten (30%; 17-47) of 33, 18 (86%; 65-95) of 21, and four (11%; 4-25) of 36, respectively, who did not receive a boost. The vaccine was well tolerated; no toxicities were reported in 75 (54%) of 140 patients with cancer following the first dose of BNT162b2, and in 22 (71%) of 31 patients with cancer following the second dose. Similarly, no toxicities were reported in 15 (38%) of 40 healthy controls after the first dose and in five (31%) of 16 after the second dose. Injection-site pain within 7 days following the first dose was the most commonly reported local reaction (23 [35%] of 65 patients with cancer; 12 [48%] of 25 healthy controls). No vaccine-related deaths were reported. INTERPRETATION: In patients with cancer, one dose of the BNT162b2 vaccine yields poor efficacy. Immunogenicity increased significantly in patients with solid cancer within 2 weeks of a vaccine boost at day 21 after the first dose. These data support prioritisation of patients with cancer for an early (day 21) second dose of the BNT162b2 vaccine. FUNDING: King's College London, Cancer Research UK, Wellcome Trust, Rosetrees Trust, and Francis Crick Institute.


Subject(s)
COVID-19 Vaccines/therapeutic use , COVID-19/immunology , Neoplasms/immunology , Adult , Aged , Aged, 80 and over , Antibodies, Viral/blood , COVID-19/blood , COVID-19/complications , COVID-19/virology , COVID-19 Vaccines/immunology , Dose-Response Relationship, Immunologic , Female , Humans , Immunogenicity, Vaccine/immunology , London/epidemiology , Male , Middle Aged , Neoplasms/blood , Neoplasms/complications , Neoplasms/virology , Prospective Studies , SARS-CoV-2 , Wales
6.
Mayo Clin Proc ; 96(6): 1418-1425, 2021 06.
Article in English | MEDLINE | ID: covidwho-1492380

ABSTRACT

OBJECTIVE: To report experience with fecal microbiota transplantation (FMT) for recurrent Clostridioides difficile infection (rCDI) and provide recommendations for management of rCDI and donor testing during the COVID-19 pandemic. METHODS: A retrospective study of patients with rCDI who underwent FMT from May 26, 2020, to September 30, 2020, with stool from well-screened donors with health and infectious screening and a newly implemented strategy for COVID-19 screening with every 2-week bookend testing with stool quarantine. Patients were followed up for development of rCDI and COVID-19. RESULTS: Of the 57 patients who underwent FMT for rCDI, 29 were tested for COVID-19 via nasopharyngeal polymerase chain reaction (PCR) and 22 via serology. All results were negative, except for 1 positive serology. Donor testing every 2 weeks for COVID-19 via serology and nasopharyngeal swab PCR was negative, except for 2 donors at 1 center who were excluded. Three patients had rCDI after FMT, and 1 underwent repeat FMT. One patient developed respiratory symptoms suggestive of COVID-19 and tested negative via nasopharyngeal PCR. Eleven patients who underwent COVID-19 testing for elective procedures or hospitalizations tested negative. No SARS-CoV-2 transmission was noted. CONCLUSIONS: With appropriate donor screening, FMT can be performed safely for rCDI during the COVID-19 pandemic. Development of a validated stool assay for SARS-CoV-2 will simplify this process further.


Subject(s)
COVID-19/epidemiology , Clostridioides difficile , Clostridium Infections/therapy , Fecal Microbiota Transplantation , Adult , Aged , Aged, 80 and over , COVID-19/diagnosis , COVID-19/prevention & control , Fecal Microbiota Transplantation/adverse effects , Fecal Microbiota Transplantation/methods , Female , Humans , Male , Middle Aged , Retrospective Studies , SARS-CoV-2 , Young Adult
7.
Rev Rhum Ed Fr ; 88(5): 377-381, 2021 Oct.
Article in French | MEDLINE | ID: covidwho-1447100

ABSTRACT

OBJECTIF: Cette étude a pour objectif de déterminer la prévalence du coronavirus 2 du syndrome respiratoire aigu sévère (SARS-CoV-2) 2019 (COVID-19) chez des patients adultes traités par biothérapies ou inhibiteurs des JAK pour des rhumatismes inflammatoires chroniques, en particulier des arthrites inflammatoires chroniques. MÉTHODES: Pour cela, une étude basée sur la population, dans la province d'Udine (466 700 habitants d'âge > 15 ans, région du Frioul-Vénétie-Julienne, Italie) a été planifiée. Le critère principal de jugement était la prévalence du COVID-19 durant les deux premiers mois de l'épidémie. Tous les patients de notre province atteints de maladies rhumatismales et traités par biothérapies ou inhibiteurs des JAK au cours des 6 mois précédents ont été inclus (n = 1051). RÉSULTATS: Du 29 février au 25 avril 2020, 4 patients adultes (4/1051, 3,8/1000, IC 95 % 1,5-9,7/1000) ont été testés positifs au COVID-19 par RT-PCR et écouvillon. Au total, 47/1051 patients (4,5 %) ont été soumis au test COVID-19 par RT-PCR durant la même période, en raison de symptômes compatibles avec le COVID-19 pour 15 d'entre eux. Dans la population générale, la prévalence était de 937 cas/466700 (2/1000, IC 95 % 1,9-2,1/1000, valeur p = 0,33, test du Chi2), et 20 179/466 700 (4,3 %) prélèvements COVID-19 sur écouvillon ont été effectués. CONCLUSION: Le risque de COVID-19 chez les patients atteints de maladies rhumatismales et traités par biothérapies ou inhibiteurs des JAK n'apparaît pas différent de celui observé dans la population générale. Les patients doivent être encouragés à poursuivre en toute sécurité leur traitement et à respecter les mesures de prévention et de protection contre le COVID-19.

8.
Ghana Med J ; 54(4 Suppl): 52-61, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-1436195

ABSTRACT

INTRODUCTION: Since the declaration of COVID-19 by the World Health Organisation (WHO) as a global pandemic on 11th March 2020, the number of deaths continue to increase worldwide. Reports on its pathologic manifestations have been published with very few from the Sub-Saharan African region. This article reports autopsies on COVID-19 patients from the Ga-East and the 37 Military Hospitals to provide pathological evidence for better understanding of COVID-19 in Ghana. METHODS: Under conditions required for carrying out autopsies on bodies infected with category three infectious agents, with few modifications, complete autopsies were performed on twenty patients with ante-mortem and/or postmortem RT -PCR confirmed positive COVID-19 results, between April and June, 2020. RESULTS: There were equal proportion of males and females. Thirteen (65%) of the patients were 55years or older with the same percentage (65%) having Type II diabetes and/or hypertension. The most significant pathological feature found at autopsy was diffuse alveolar damage. Seventy per cent (14/20) had associated thromboemboli in the lungs, kidneys and the heart. Forty per cent (6/15) of the patients that had negative results for COVID-19 by the nasopharyngeal swab test before death had positive results during postmortem using bronchopulmonary specimen. At autopsy all patients were identified to have pre-existing medical conditions. CONCLUSION: Diffuse alveolar damage was a key pathological feature of deaths caused by COVID-19 in all cases studied with hypertension and diabetes mellitus being major risk factors. Individuals without co-morbidities were less likely to die or suffer severe disease from SARS-CoV-2. FUNDING: None declared.


Subject(s)
Autopsy/statistics & numerical data , COVID-19/pathology , Hospitals, Military/statistics & numerical data , Hospitals, Municipal/statistics & numerical data , SARS-CoV-2 , COVID-19/mortality , COVID-19 Testing/methods , COVID-19 Testing/statistics & numerical data , Comorbidity , Diabetes Mellitus, Type 2/mortality , Diabetes Mellitus, Type 2/virology , Female , Ghana/epidemiology , Humans , Hypertension/mortality , Hypertension/virology , Lung/pathology , Lung/virology , Male , Middle Aged , Pulmonary Alveoli/pathology , Pulmonary Alveoli/virology , Risk Factors
9.
Clin Infect Dis ; 73(6): e1321-e1328, 2021 09 15.
Article in English | MEDLINE | ID: covidwho-1412386

ABSTRACT

BACKGROUND: Healthcare workers (HCWs) in Zambia have become infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19). However, SARS-CoV-2 prevalence among HCWs is not known in Zambia. METHODS: We conducted a cross-sectional SARS-CoV-2 prevalence survey among Zambian HCWs in 20 health facilities in 6 districts in July 2020. Participants were tested for SARS-CoV-2 infection using polymerase chain reaction (PCR) and for SARS-CoV-2 antibodies using enzyme-linked immunosorbent assay (ELISA). Prevalence estimates and 95% confidence intervals (CIs), adjusted for health facility clustering, were calculated for each test separately, and a combined measure for those who had PCR and ELISA was performed. RESULTS: In total, 660 HCWs participated in the study, with 450 (68.2%) providing a nasopharyngeal swab for PCR and 575 (87.1%) providing a blood specimen for ELISA. Sixty-six percent of participants were females, and median age was 31.5 years (interquartile range, 26.2-39.8). The overall prevalence of the combined measure was 9.3% (95% CI, 3.8%-14.7%). PCR-positive prevalence of SARS-CoV-2 was 6.6% (95% CI, 2.0%-11.1%), and ELISA-positive prevalence was 2.2% (95% CI, .5%-3.9%). CONCLUSIONS: SARS-CoV-2 prevalence among HCWs was similar to a population-based estimate (10.6%) during a period of community transmission in Zambia. Public health measures such as establishing COVID-19 treatment centers before the first cases, screening for COVID-19 symptoms among patients who access health facilities, infection prevention and control trainings, and targeted distribution of personal protective equipment based on exposure risk might have prevented increased SARS-CoV-2 transmission among Zambian HCWs.


Subject(s)
COVID-19 , SARS-CoV-2 , Adult , COVID-19/drug therapy , Cross-Sectional Studies , Female , Health Personnel , Humans , Prevalence , Zambia
10.
medRxiv ; 2020 Dec 08.
Article in English | MEDLINE | ID: covidwho-1383294

ABSTRACT

Unsupervised upper respiratory specimen collection is a key factor in the ability to massively scale SARS-CoV-2 testing. But there is concern that unsupervised specimen collection may produce inferior samples. Across two studies that included unsupervised at-home mid-turbinate specimen collection, ∼1% of participants used the wrong end of the swab. We found that molecular detection of respiratory pathogens and a human biomarker were comparable between specimens collected from the handle of the swab and those collected correctly. Older participants were more likely to use the swab backwards. Our results suggest that errors made during home-collection of nasal specimens do not preclude molecular detection of pathogens and specialized swabs may be an unnecessary luxury during a pandemic.

11.
J Med Virol ; 93(9): 5333-5338, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1363672

ABSTRACT

The accurate laboratory detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a crucial element in the fight against coronavirus disease 2019 (COVID-19). Reverse transcription-polymerase chain reaction testing on combined oral and nasopharyngeal swab (ONPS) suffers from several limitations, including the need for qualified personnel, the discomfort caused by invasive nasopharyngeal sample collection, and the possibility of swab and transport media shortage. Testing on saliva would represent an advancement. The aim of this study was to compare the concordance between saliva samples and ONPS for the detection of SARS-CoV-2 on various commercial and laboratory-developed tests (LDT). Individuals were recruited from eight institutions in Quebec, Canada, if they had SARS-CoV-2 RNA detected on a recently collected ONPS, and accepted to provide another ONPS, paired with saliva. Assays available in the different laboratories (Abbott RealTime SARS-CoV-2, Cobas® SARS-CoV-2, Simplexa™ COVID-19 Direct, Allplex™ 2019-nCoV, RIDA®GENE SARS-CoV-2, and an LDT preceded by three different extraction methods) were used to determine the concordance between saliva and ONPS results. Overall, 320 tests were run from a total of 125 saliva and ONPS sample pairs. All assays yielded similar sensitivity when saliva was compared to ONPS, with the exception of one LDT (67% vs. 93%). The mean difference in cycle threshold (∆C t ) was generally (but not significantly) in favor of the ONPS for all nucleic acid amplification tests. The maximum mean ∆​​​​​C t was 2.0, while individual ∆C t varied importantly from -17.5 to 12.4. Saliva seems to be associated with sensitivity similar to ONPS for the detection of SARS-CoV-2 by various assays.


Subject(s)
COVID-19 Nucleic Acid Testing/standards , COVID-19/diagnosis , Diagnostic Tests, Routine/standards , RNA, Viral/genetics , SARS-CoV-2/genetics , COVID-19/epidemiology , COVID-19/virology , COVID-19 Nucleic Acid Testing/instrumentation , COVID-19 Nucleic Acid Testing/methods , Diagnostic Tests, Routine/instrumentation , Diagnostic Tests, Routine/methods , Humans , Mouth/virology , Nasopharynx/virology , Quebec/epidemiology , Saliva/virology , Sensitivity and Specificity , Specimen Handling/standards
12.
J Pediatric Infect Dis Soc ; 10(6): 714-721, 2021 Aug 14.
Article in English | MEDLINE | ID: covidwho-1358467

ABSTRACT

BACKGROUND: Children with coronavirus disease-2019 (COVID-19) have a milder clinical course than adults. We describe the spectrum of cardiovascular manifestations during a COVID-19 outbreak in Emilia-Romagna, Italy. METHODS: A cross-sectional multicenter study was performed, including all patients diagnosed with Kawasaki disease (KD), myocarditis, and multisystem inflammatory syndrome in children (MIS-C) from February to April 2020. KD patients were compared with those diagnosed before the epidemic. RESULTS: KD: 8 patients (6/8 boys, all negative for severe acute respiratory syndrome coronavirus-2 [SARS-CoV-2]): complete presentation in 5/8, 7/8 immunoglobulin (IVIG) responders, and 3/8 showed transient coronary lesions (CALs). Myocarditis: one 5-year-old girl negative for SARS-CoV-2 and positive for parvovirus B19. She responded to IVIG. MIS-C: 4 SARS-CoV-2-positive boys (3 patients with positive swab and serology and 1 patient with negative swab and positive serology): 3 presented myocardial dysfunction and pericardial effusion, and 1 developed multicoronary aneurysms and hyperinflammation; all responded to treatment. The fourth boy had mitral and aortic regurgitation that rapidly regressed after steroids. CONCLUSIONS: KD, myocarditis, and MIS-C were distinguishable cardiovascular manifestations. KD did not show a more aggressive form compared with previous years: coronary involvement was frequent but always transient. MIS-C and myocarditis rapidly responded to treatment without cardiac sequelae despite high markers of myocardial injury at the onset, suggesting a myocardial depression due to systemic inflammation rather than focal necrosis. Evidence of actual or previous SARS-CoV-2 infection was documented only in patients with MIS-C.


Subject(s)
COVID-19 , Cardiovascular Diseases , Adolescent , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/etiology , Child , Cross-Sectional Studies , Female , Humans , Male , SARS-CoV-2 , Systemic Inflammatory Response Syndrome
13.
Clin Infect Dis ; 73(3): e559-e565, 2021 08 02.
Article in English | MEDLINE | ID: covidwho-1338669

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) has rapidly evolved to become a global pandemic, largely owing to the transmission of its causative virus through asymptomatic carriers. Detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in asymptomatic people is an urgent priority for the prevention and containment of disease outbreaks in communities. However, few data are available in asymptomatic persons regarding the accuracy of polymerase chain reaction testing. In addition, although self-collected saliva samples have significant logistical advantages in mass screening, their utility as an alternative specimen in asymptomatic persons is yet to be determined. METHODS: We conducted a mass screening study to compare the utility of nucleic acid amplification, such as reverse-transcription polymerase chain reaction testing, using nasopharyngeal swab (NPS) and saliva samples from each individual in 2 cohorts of asymptomatic persons: the contact-tracing cohort and the airport quarantine cohort. RESULTS: In this mass screening study including 1924 individuals, the sensitivities of nucleic acid amplification testing with NPS and saliva specimens were 86% (90% credible interval, 77%-93%) and 92% (83%-97%), respectively, with specificities >99.9%. The true concordance probability between the NPS and saliva tests was estimated at 0.998 (90% credible interval, .996-.999) given the recent airport prevalence of 0.3%. In individuals testing positive, viral load was highly correlated between NPS and saliva specimens. CONCLUSION: Both NPS and saliva specimens had high sensitivity and specificity. Self-collected saliva specimens are valuable for detecting SARS-CoV-2 in mass screening of asymptomatic persons.


Subject(s)
COVID-19 , SARS-CoV-2 , Humans , Mass Screening , Saliva , Specimen Handling
14.
Lancet Respir Med ; 9(7): 712-720, 2021 07.
Article in English | MEDLINE | ID: covidwho-1337036

ABSTRACT

BACKGROUND: Whether young adults who are infected with SARS-CoV-2 are at risk of subsequent infection is uncertain. We investigated the risk of subsequent SARS-CoV-2 infection among young adults seropositive for a previous infection. METHODS: This analysis was performed as part of the prospective COVID-19 Health Action Response for Marines study (CHARM). CHARM included predominantly male US Marine recruits, aged 18-20 years, following a 2-week unsupervised quarantine at home. After the home quarantine period, upon arrival at a Marine-supervised 2-week quarantine facility (college campus or hotel), participants were enrolled and were assessed for baseline SARS-CoV-2 IgG seropositivity, defined as a dilution of 1:150 or more on receptor-binding domain and full-length spike protein ELISA. Participants also completed a questionnaire consisting of demographic information, risk factors, reporting of 14 specific COVID-19-related symptoms or any other unspecified symptom, and brief medical history. SARS-CoV-2 infection was assessed by PCR at weeks 0, 1, and 2 of quarantine and participants completed a follow-up questionnaire, which included questions about the same COVID-19-related symptoms since the last study visit. Participants were excluded at this stage if they had a positive PCR test during quarantine. Participants who had three negative swab PCR results during quarantine and a baseline serum serology test at the beginning of the supervised quarantine that identified them as seronegative or seropositive for SARS-CoV-2 then went on to basic training at Marine Corps Recruit Depot-Parris Island. Three PCR tests were done at weeks 2, 4, and 6 in both seropositive and seronegative groups, along with the follow-up symptom questionnaire and baseline neutralising antibody titres on all subsequently infected seropositive and selected seropositive uninfected participants (prospective study period). FINDINGS: Between May 11, 2020, and Nov 2, 2020, we enrolled 3249 participants, of whom 3168 (98%) continued into the 2-week quarantine period. 3076 (95%) participants, 2825 (92%) of whom were men, were then followed up during the prospective study period after quarantine for 6 weeks. Among 189 seropositive participants, 19 (10%) had at least one positive PCR test for SARS-CoV-2 during the 6-week follow-up (1·1 cases per person-year). In contrast, 1079 (48%) of 2247 seronegative participants tested positive (6·2 cases per person-year). The incidence rate ratio was 0·18 (95% CI 0·11-0·28; p<0·001). Among seropositive recruits, infection was more likely with lower baseline full-length spike protein IgG titres than in those with higher baseline full-length spike protein IgG titres (hazard ratio 0·45 [95% CI 0·32-0·65]; p<0·001). Infected seropositive participants had viral loads that were about 10-times lower than those of infected seronegative participants (ORF1ab gene cycle threshold difference 3·95 [95% CI 1·23-6·67]; p=0·004). Among seropositive participants, baseline neutralising titres were detected in 45 (83%) of 54 uninfected and in six (32%) of 19 infected participants during the 6 weeks of observation (ID50 difference p<0·0001). INTERPRETATION: Seropositive young adults had about one-fifth the risk of subsequent infection compared with seronegative individuals. Although antibodies induced by initial infection are largely protective, they do not guarantee effective SARS-CoV-2 neutralisation activity or immunity against subsequent infection. These findings might be relevant for optimisation of mass vaccination strategies. FUNDING: Defense Health Agency and Defense Advanced Research Projects Agency.


Subject(s)
Antibodies, Viral/blood , COVID-19/blood , COVID-19/epidemiology , SARS-CoV-2/immunology , Adolescent , COVID-19/diagnosis , COVID-19 Serological Testing , Cohort Studies , Female , Humans , Male , Prospective Studies , Quarantine , Risk Assessment , Young Adult
15.
JAMA ; 325(24): 2457-2465, 2021 Jun 22.
Article in English | MEDLINE | ID: covidwho-1318647

ABSTRACT

IMPORTANCE: Randomized clinical trials have provided estimates of the effectiveness of the BNT162b2 vaccine against symptomatic SARS-CoV-2 infection, but its effect on asymptomatic infections remains unclear. OBJECTIVE: To estimate the association of vaccination with the Pfizer-BioNTech BNT162b2 vaccine with symptomatic and asymptomatic SARS-CoV-2 infections among health care workers. DESIGN, SETTING, AND PARTICIPANTS: This was a single-center, retrospective cohort study conducted at a tertiary medical center in Tel Aviv, Israel. Data were collected on symptomatic and asymptomatic SARS-CoV-2 infections confirmed via polymerase chain reaction (PCR) tests in health care workers undergoing regular screening with nasopharyngeal swabs between December 20, 2020, and February 25, 2021. Logistic regression was used to calculate incidence rate ratios (IRRs) comparing the incidence of infection between fully vaccinated and unvaccinated participants, controlling for demographics and the number of PCR tests performed. EXPOSURES: Vaccination with the BNT162b2 vaccine vs unvaccinated status was ascertained from the employee health database. Full vaccination was defined as more than 7 days after receipt of the second vaccine dose. MAIN OUTCOMES AND MEASURES: The primary outcome was the regression-adjusted IRR for symptomatic and asymptomatic SARS-CoV-2 infection of fully vaccinated vs unvaccinated health care workers. The secondary outcomes included IRRs for partially vaccinated health care workers (days 7-28 after first dose) and for those considered as late fully vaccinated (>21 days after second dose). RESULTS: A total of 6710 health care workers (mean [SD] age, 44.3 [12.5] years; 4465 [66.5%] women) were followed up for a median period of 63 days; 5953 health care workers (88.7%) received at least 1 dose of the BNT162b2 vaccine, 5517 (82.2%) received 2 doses, and 757 (11.3%) were not vaccinated. Vaccination was associated with older age compared with those who were not vaccinated (mean age, 44.8 vs 40.7 years, respectively) and male sex (31.4% vs 17.7%). Symptomatic SARS-CoV-2 infection occurred in 8 fully vaccinated health care workers and 38 unvaccinated health care workers (incidence rate, 4.7 vs 149.8 per 100 000 person-days, respectively, adjusted IRR, 0.03 [95% CI, 0.01-0.06]). Asymptomatic SARS-CoV-2 infection occurred in 19 fully vaccinated health care workers and 17 unvaccinated health care workers (incidence rate, 11.3 vs 67.0 per 100 000 person-days, respectively, adjusted IRR, 0.14 [95% CI, 0.07-0.31]). The results were qualitatively unchanged by the propensity score sensitivity analysis. CONCLUSIONS AND RELEVANCE: Among health care workers at a single center in Tel Aviv, Israel, receipt of the BNT162b2 vaccine compared with no vaccine was associated with a significantly lower incidence of symptomatic and asymptomatic SARS-CoV-2 infection more than 7 days after the second dose. Findings are limited by the observational design.


Subject(s)
COVID-19 Vaccines , COVID-19/epidemiology , Health Personnel , Adult , Asymptomatic Infections/epidemiology , COVID-19/diagnosis , COVID-19/prevention & control , Female , Humans , Incidence , Israel , Male , Middle Aged , Polymerase Chain Reaction , Propensity Score , Retrospective Studies , SARS-CoV-2/isolation & purification , Tertiary Care Centers
16.
Stroke Vasc Neurol ; 5(4): 331-336, 2020 12.
Article in English | MEDLINE | ID: covidwho-1318206

ABSTRACT

BACKGROUND: COVID-19, caused by SARS-CoV-2, is a global pandemic that has been an immense burden on healthcare systems all over the world. These patients may be at higher risk for acute ischaemic stroke (AIS). We present our experience with AIS in patients with COVID-19. METHODS: We reviewed all patients admitted to our hospital during a 6-week period with a positive nasopharyngeal swab test for SARS-CoV-2. Among these patients, we identified AIS. We reviewed the demographics, clinical, laboratory, imaging characteristics, treatments received and outcomes of AIS in patients with COVID-19. RESULTS: We identified 683 patients admitted with COVID-19 during the study period, of which 20 patients had AIS. Large-vessel occlusion (LVO) was noted in 11 patients (55%). Intravenous alteplase was administered in four patients (20%) and mechanical thrombectomy was performed in five patients (25%). Respiratory symptoms preceded the onset of AIS in most of the patients (70%) by 1 to 21 days. Mortality in patients with AIS was 50% compared with 26% of all COVID-19 admissions. Most of these patients died due to non-neurological causes (70%). Three patients with AIS had clinical and imaging findings consistent with COVID-19, but were negative for multiple nasopharyngeal swab tests. INTERPRETATION: LVO was more common in patients with AIS and COVID-19. They had more severe disease and higher mortality rates. Most of the patients had respiratory symptoms preceding AIS by days to weeks. This could explain certain patients with clinical picture of COVID-19 but negative nasopharyngeal swab tests.


Subject(s)
Brain Ischemia , COVID-19 , Stroke , Humans , Pandemics , SARS-CoV-2 , Stroke/diagnosis , Thrombectomy
17.
Sci Prog ; 104(2): 368504211026152, 2021.
Article in English | MEDLINE | ID: covidwho-1277845

ABSTRACT

The most common method for SARS-CoV-2 testing is throat or nasal swabbing by real-time reverse transcription polymerase chain reaction (RT-PCR) assay. In South Korea, drive-through swab test is used for screening system and community treatment centers (CTCs), which admit and treat confirmed COVID-19 patients with mild symptoms, are being used. This retrospective study was conducted on patients admitted to a CTC on March 6, 2020. A total of 313 patients were admitted. The nasal and throat swabs were collected from the upper respiratory tract, and a sputum test was performed to obtain lower respiratory samples. The positive rate of the first set of test, sputum test was higher than that of the swab test (p = 0.011). In the second set of test, 1 week after the first ones, the rate of positive swab tests was relatively high (p = 0.026). In the first set of test, 66 of 152 (43.4%) patients showed 24-h consecutive negative swab test results, when the sputum test results were considered together, that number fell to 29 patients (19.1%) (p < 0.001). Also, in the second set of test, 63 of 164 (38.4%) patients met the discharge criteria only when the swab test was considered; that number fell to 30 (18.3%) when the sputum test results were also considered (p < 0.001). Using the swab test alone is insufficient for screening test and discharge decision. Patients who may have positive result in the sputum test can be missed.


Subject(s)
COVID-19 Nucleic Acid Testing/standards , COVID-19/diagnosis , Patient Discharge/statistics & numerical data , SARS-CoV-2/genetics , Specimen Handling/methods , Adult , Asymptomatic Diseases , COVID-19/epidemiology , COVID-19/virology , Community Health Centers/organization & administration , Female , Humans , Male , Mass Screening/methods , Nasopharynx/virology , Pharynx/virology , Quarantine/methods , Republic of Korea/epidemiology , Retrospective Studies , Severity of Illness Index , Sputum/virology
18.
Diabetol Metab Syndr ; 13(1): 65, 2021 Jun 13.
Article in English | MEDLINE | ID: covidwho-1270930

ABSTRACT

BACKGROUND: A new strain of human coronavirus (HCoV) spread rapidly around the world. Diabetes and obesity are associated with a worse prognosis in these patients. Congenital Generalized Lipodystrophy (CGL) patients generally have poorly controlled diabetes and require extremely high doses of insulin. There is no documentation in the literature of cases of COVID in CGL patients. Thus, we aimed to evaluate the prevalence of SARS-CoV-2 infection in CGL patients, and the association of their clinical and metabolic characteristics and outcomes. METHODS: This is a cross-sectional study carried out between July and October 2020. Clinical data collected were respiratory or other flu-like symptoms, need of hospitalization in the last three months, CGL comorbidities, and medications in use. Cholesterol, triglycerides, glycohemoglobin A1c levels, anti-SARS-CoV-2 antibodies and nasopharyngeal swab for RT-qPCR were also obtained in all CGL patients. Mann-Whitney U test was used to analyze the characteristics of the participants, verifying the non-adherence of the data to the Gaussian distribution. In investigating the association between categorical variables, we used Pearson's chi-square test and Fisher's exact test. A significance level of 5% was adopted. RESULTS: Twenty-two CGL patients were assessed. Eight subjects (36.4%) had reactive anti-SARS-CoV-2 antibodies. Only one of these, also presented detectable RT-qPCR. Five individuals (62.5%) were women, median age of 13.5 years (1 to 37). Symptoms like fever, malaise, nausea, diarrhea and chest pain were present, and all asymptomatic patients were children. All subjects had inadequate metabolic control, with no difference between groups. Among positive individuals there was no difference between those with AGPAT2 (75%) and BSCL2 gene mutations (25%) (p > 0.05). No patient needed hospitalization or died. CONCLUSIONS: We described a high prevalence of SARS-CoV-2 infection in CGL patients with a good outcome in all of them. These findings suggest that at least young CGL patients infected by SARS-COV-2 are not at higher risk of poor outcome, despite known severe metabolic comorbidities.

19.
PLoS One ; 16(6): e0253007, 2021.
Article in English | MEDLINE | ID: covidwho-1264226

ABSTRACT

BACKGROUND: Diagnosis of COVID-19 in symptomatic patients and screening of populations for SARS-CoV-2 infection require access to straightforward, low-cost and high-throughput testing. The recommended nasopharyngeal swab tests are limited by the need of trained professionals and specific consumables and this procedure is poorly accepted as a screening method In contrast, saliva sampling can be self-administered. METHODS: In order to compare saliva and nasopharyngeal/oropharyngeal samples for the detection of SARS-CoV-2, we designed a meta-analysis searching in PubMed up to December 29th, 2020 with the key words "(SARS-CoV-2 OR COVID-19 OR COVID19) AND (salivary OR saliva OR oral fluid)) NOT (review[Publication Type]) NOT (PrePrint[Publication Type])" applying the following criteria: records published in peer reviewed scientific journals, in English, with at least 15 nasopharyngeal/orapharyngeal swabs and saliva paired samples tested by RT-PCR, studies with available raw data including numbers of positive and negative tests with the two sampling methods. For all studies, concordance and sensitivity were calculated and then pooled in a random-effects model. FINDINGS: A total of 377 studies were retrieved, of which 50 were eligible, reporting on 16,473 pairs of nasopharyngeal/oropharyngeal and saliva samples. Meta-analysis showed high concordance, 92.5% (95%CI: 89.5-94.7), across studies and pooled sensitivities of 86.5% (95%CI: 83.4-89.1) and 92.0% (95%CI: 89.1-94.2) from saliva and nasopharyngeal/oropharyngeal swabs respectively. Heterogeneity across studies was 72.0% for saliva and 85.0% for nasopharyngeal/oropharyngeal swabs. INTERPRETATION: Our meta-analysis strongly suggests that saliva could be used for frequent testing of COVID-19 patients and "en masse" screening of populations.


Subject(s)
COVID-19 Nucleic Acid Testing/methods , COVID-19/diagnosis , Nasopharynx/virology , RNA, Viral/analysis , SARS-CoV-2/isolation & purification , Saliva/virology , Humans , RNA, Viral/genetics , SARS-CoV-2/genetics , Sensitivity and Specificity , Specimen Handling/methods
20.
Clin Transl Gastroenterol ; 12(6): e00363, 2021 06 09.
Article in English | MEDLINE | ID: covidwho-1262701

ABSTRACT

INTRODUCTION: Mounting evidence demonstrates potential for fecal-oral transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The US Food and Drug Administration now requires SARS-CoV-2 testing of potential feces donors before the use of stool manufactured for fecal microbiota transplantation. We sought to develop and validate a high-sensitivity SARS-CoV-2 reverse transcriptase polymerase chain reaction (RT-PCR) procedure for testing stool specimens. METHODS: A modified extraction method was used with an RT-PCR assay adapted from the Centers for Disease Control and Prevention PCR protocol for respiratory specimens. Contrived specimens were created using pre-COVID-19 banked stool specimens and spiking in known concentrations of SARS-CoV-2-specific nucleic acid. The highest transcript concentration at which 2/2 or 1/2 SARS-CoV-2 targets were detected in 9/10 replicates was defined as the dual-target limit and single-target limit of detection, respectively. The clinical performance of the assay was evaluated with stool samples collected from 17 nasopharyngeal swab RT-PCR-positive patients and 14 nasopharyngeal RT-PCR-negative patients. RESULTS: The dual-target and single-target limit of detection were 56 copies/µL and 3 copies/µL, respectively. SARS-CoV-2 was detected at concentrations as low as 0.6 copies/µL. Clinical stool samples from known COVID-19-positive patients demonstrated the detection of SARS-CoV-2 in stool up to 29 days from symptom onset with a high agreement with nasopharyngeal swab tests (kappa statistic of 0.95, P value < 0.001). DISCUSSION: The described RT-PCR test is a sensitive and flexible approach for the detection of SARS-CoV-2 in stool specimens. We propose an integrated screening approach that incorporates this stool test to support continuation of fecal microbiota transplantation programs.


Subject(s)
COVID-19 Testing/methods , COVID-19/transmission , Fecal Microbiota Transplantation/methods , Feces/virology , SARS-CoV-2/genetics , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/virology , COVID-19 Testing/statistics & numerical data , Centers for Disease Control and Prevention, U.S./standards , Fecal Microbiota Transplantation/statistics & numerical data , Humans , Nasopharynx/virology , RNA, Viral/genetics , Reverse Transcriptase Polymerase Chain Reaction/methods , SARS-CoV-2/isolation & purification , Tissue Donors/supply & distribution , United States
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